FDA Approves Nexterone
Prism Pharmaceuticals Receives FDA Approval of Nexterone for Life-Threatening Ventricular Fibrillation and Ventricular Tachycardia
KING OF PRUSSIA, Pa., January 05, 2009 /PRNewswire/ -- Prism Pharmaceuticals announced today that the U.S. Food & Drug Administration (FDA) has approved the new drug application (NDA) for Nexterone (amiodarone HCl) Injection, a novel, patent-protected, cosolvent free formulation of the antiarrhythmic agent Amiodarone IV, originally marketed in the US by Wyeth as Cordarone Intravenous. Nexterone is indicated for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.
"Approval of our first product is an important corporate milestone and validates our accelerated development model, which allowed us to move Nexterone from licensing to FDA clearance in less than three years and ahead of the PDUFA target date," said Dr. Warren D. Cooper, President and CEO of Prism. "We developed Nexterone to overcome solvent-based limitations of conventional intravenous amiodarone and to improve patient care and overall medication management in the setting of life-threatening cardiac arrhythmias."
Nexterone represents the first product to successfully overcome the long recognized solubility issues of amiodarone by removing the original cosolvents polysorbate 80 and benzyl alcohol. As a result of removing these cosolvents, Nexterone does not have many of the product administration limitations regarding compatibility and stability with plastics and ionic infusion fluids, which are included in the labeling of conventional intravenous amiodarone. Importantly, Nexterone does not carry the specific warning about the risk of fatal gasping syndrome in newborn infants because it does not contain benzyl alcohol.
Improving medication safety in the hospital environment is an area of significant and current attention. This agenda is being driven by entities such as The Joint Commission, which is responsible for the accreditation of hospitals, and the Institute for Safe Medication Practices. Providing injectable products, especially those for critical care use, in premixed, ready to use forms is a high priority solution to minimize medication errors.
Dr. Cooper continued, "While this regulatory approval is for Nexterone supplied in vials and a prefilled syringe, the changes in the compatibility and stability profile of Nexterone, brought about by the removal of polysorbate 80 and benzyl alcohol, present the opportunity to formulate intravenous amiodarone for the first time in premixed, ready to use configurations."
Prism is currently implementing a full scale manufacturing development program with the Medication Delivery business of Baxter Healthcare Corporation, a world leader in premix technologies. Prism intends to submit a supplemental NDA for the premixed configurations which will form the focus of the commercial launch of Nexterone as a complete product line. Health-System Pharmacists hold the primary management responsibility for improvements in medication safety in hospitals and this will be a key target customer group for Nexterone.
"We intend to commercialize Nexterone ourselves in the US with partners that are well positioned in the hospital marketplace and will seek to license the ex-US worldwide rights," said Dr. Cooper. "As we round out the Nexterone product line with the premixed bag configurations, we are concurrently defining the best approach to launch the brand, drive rapid conversion and optimize the value of Nexterone to pharmacists, clinicians, patients and the Company. I believe Nexterone can rapidly replace generic Amiodarone IV when it becomes available and has the potential to eventually render conventional Amiodarone IV obsolete."
The FDA approval of Nexterone triggers a second $10M milestone payment from Paul Capital. This long range financing agreement, established in September 2006, provides Prism with non-dilutive capital to enable the company to bring Nexterone through the period of NDA review and commercial launch.
About Ventricular Fibrillation and Ventricular Tachycardia
Ventricular fibrillation is a condition in which the heart's electrical activity becomes disordered. When this happens, the heart's lower (pumping) chambers contract in a rapid, unsynchronized way. (The ventricles "flutter" rather than beat.) The heart pumps little or no blood. Ventricular fibrillation is very serious. Collapse and sudden cardiac death will follow in minutes unless medical help is provided immediately.
Ventricular tachycardia is a fast or rapid heart rate that starts in the heart's lower chambers (ventricles). Ventricular tachycardia may result from serious heart disease and usually requires prompt treatment.
Important Safety Information About Nexterone
The most important treatment-emergent adverse effects associated with intravenous amiodarone therapy in clinical studies were hypotension, asystole/cardiac arrest/electromechanical dissociation (EMD), cardiogenic shock, congestive heart failure, bradycardia, liver function test abnormalities, ventricular tachycardia, and atrioventricular block. Overall, treatment was discontinued for about 9 percent of the patients because of adverse effects. The most common adverse effects leading to discontinuation of intravenous amiodarone therapy were hypotension (1.6 percent), asystole/cardiac arrest/EMD (1.2 percent), ventricular tachycardia (1.1 percent), and cardiogenic shock (1 percent).
Nexterone is contraindicated in patients with known hypersensitivity to any of the components of Nexterone, including iodine, or in patients with cardiogenic shock, marked sinus bradycardia, and second- or third-degree AV block unless a functioning pacemaker is available.
Nexterone is for hospital use only. Nexterone should be administered only by physicians who are experienced in the treatment of life-threatening arrhythmias, who are thoroughly familiar with the risks and benefits of intravenous amiodarone therapy, and who have access to facilities adequate for monitoring the effectiveness and side effects of treatment.
About Prism Pharmaceuticals
Prism Pharmaceuticals, based in King of Prussia, Pennsylvania, is a specialty pharmaceutical company committed to developing and commercializing acute care cardiovascular products. The product portfolio strategy is focused on recognizing unfulfilled opportunities in existing compounds that address current unmet medical needs with a specific focus on medication safety in the hospital environment.
Prism was started in 2004 with a founding investment from Essex Woodlands Health Ventures. In 2006 Prism secured a $68M layered financing of equity from Essex combined with equity and a revenue interest agreement from Paul Capital. This level of sustaining investment has enabled Prism to pursue an aggressive licensing and rapid development model resulting in the successful approval of Nexterone.
The worldwide rights to Nexterone were licensed in early 2006 from CyDex Pharmaceuticals . Nexterone is based on the CyDex patent-protected CAPTISOL technology platform. Prism and CyDex are also developing a novel injectable form of the blockbuster antiplatelet agent PLAVIX (clopidogrel) for use in acute care situations overcoming the limitations of the current product which is only available as an oral therapy.
Nexterone is a registered trademark of Prism Pharmaceuticals, Inc. Cordarone and PLAVIX are registered trademarks of Sanofi-Aventis.
Posted: January 2009
- Prism Pharmaceuticals Receives FDA Approval of Ready-to-Use Nexterone (Amiodarone HCl) Premixed Injection - November 19, 2010
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